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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC DEXCOM G6 SENSOR, GLUCOSE, INVASIVE

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DEXCOM INC DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number DEXCOM G6 SENSOR
Device Problem Fluid Leak (1250)
Patient Problems Itching Sensation (1943); Contact Dermatitis (4546)
Event Date 11/10/2020
Event Type  Injury  
Event Description
I have severe contact dermatitis from the adhesive used for my dexcom g6. This started about 30 days ago and is just progressing to worse. My current sensor is overly itchy and is leaking an orangish fluid from wearing the device. I haven't changed anything so it must be something dexcom is using on this batch of sensors. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM INC
MDR Report Key10837023
MDR Text Key216407215
Report NumberMW5097852
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDEXCOM G6 SENSOR
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/12/2020 Patient Sequence Number: 1
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